The Oxford Risk Factors And Non-Invasive Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250,000
- 试验地点
- 45
- 主要终点
- Progression of disease
研究概览
简要总结
ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.
详细描述
The ORFAN registry will include unselected, consecutive patients undergoing CT scans (coronary CT angiograms (CCTA), CT chest, abdomen and pelvis scans) collected at the participating centres. The study will combine imaging data with patient demographics and clinical information (including prospective outcomes) to aid the development and/or validation of new or existing image analysis algorithms and software tools to improve diagnosis, clinical risk discrimination and prediction. Specifically, ORFAN will evaluate the specificity, utility and predictive value of newly developed image analysis methods. ORFAN will recruit and follow-up patients prospectively, linking the index CT scan with blood biomarkers, genetic information as well as information on disease progression (recorded through follow-up CT scans) and clinical outcomes data.
The study will also collect CT scans performed in the past and link them with clinical factors and prospective outcomes data collected after the index scan was performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for study Arms 1, 2 and 3:
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 -99 years.
- •Inclusion Criteria for study Arm 4:
- •Male or Female, aged 18 -99 years.
排除标准
- •Exclusion Criteria for Study Arms 1, 2 and 3:
- •Unable or unwilling to consent
- •Active cancer
- •Exclusion Criteria for Study Arm 4:
- •Participation in Study Arms 1, 2 or 3
- •Existing opt-out from use of data for research purposes
研究组 & 干预措施
Group 3
Individuals where at least 6 months have elapsed from previous CCTA will undergo repeat CCTA scan and enter prospective follow up for clinical endpoints.
Group 1
Participants attending cardiology department, hypertension or outpatient clinics.
Group 2
Participants who are recruited prospectively, during their clinically indicated CT scan, and they are followed-up prospectively for clinical endpoints; A follow-up CCTA at least 6 months later will be offered to a subgroup of these patients, to assess disease progression.
Group 4
Cohort of consecutive patients who have undergone clinical CTAs or unenhanced CT chest, abdomen and pelvis in the past, linking the index CT scan with prospective outcomes collection already accumulated.
结局指标
主要结局
Progression of disease
时间窗: 15 years
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict progression of cardiometabolic diseases over a period of 15 years post index CT scan.
Cardiac and non-cardiac findings by Computed Tomography
时间窗: 15 years
Using novel image analysis methods, clinical risk factors, and blood biomarkers to detect pathology from Computed Tomography images.
Non-fatal vascular events
时间窗: 15 years
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict future non-fatal vascular events over a period of 15 years post CT scan.
Cardiac and all cause mortality
时间窗: 15 years
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict future cardiac and all-cause mortality over a period of 15 years post CT scan.
次要结局
- Cardiovascular risk factors(15 years)
- Genotyping(15 years)
- Hospital admissions for any reason classified using ICD10(15 years)
- Progression of cardiovascular disease(15 years)
- Validation and refinement of the CaRi Image analysis platform(15 years)